NHRA MDRMDR Guideline — Medical Device Classification, Ver 2.4
MDR Guideline — Medical Device Classification, Ver 2.4 is the official NHRA identifier for “Medical Device Classification Guideline, Version 2.4”. MDR Guideline — Medical Device Classification, Ver 2.4 is the official identifier NHRA uses for this instrument.
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Medical Device Classification Guideline, Version 2.4
Medical Device Classification Guideline, Version 2.4, dated 29 June 2022 — how a device's risk class is determined in Bahrain. Eight numbered sections: the introduction, the important rules, the submission for classification, the requirements of classification, classification based on level of risk, the classification rules based on product technical details, the glossary and the annex. Read against the registration guideline, this is the guideline that fixes which of the four classes an application falls into. The document's own body numbering is off by one against its table of contents: the body prints 1, 2, 2, 3, 4, 5, 6, 7 for its eight sections — a repeated "2" and no "3" — while the contents page lists eight consecutive numbers. The extract follows the body, so the block ids run sec-1 … sec-8 in body order and the duplicated number is visible in the text rather than corrected.
MDR Guideline — Medical Device Classification, Ver 2.4 is the official identifier NHRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.